Health Services ResearchPhase 1NCT07535099
Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects
A Phase 1 study testing ICP-538 Tablets in people with Health Services Research, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site in China.
Trial summary
This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Services Research
- What is being tested?
- ICP-538 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2026to Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily sign the ICF..
- BMI between 18-26 kg/m² (inclusive). Male weight ≥50 kg; female weight ≥45 kg.
- Vital signs, physical examination, ECG, Chest X-ray, Abdominal ultrasound results at screening are within normal range or showing minor deviations deemed not clinically significant by the investigator.
- Laboratory test results at screening and baseline are within the normal reference range.
- Reproductive Status：Females of non-childbearing potential . Male participants and their partners must agree to use effective contraception throughout the study and for 3 months after the last dose. Male participants must not donate sperm during this period.
Who cannot join
- Evidence or history of clinically significant diseases, or Evidence or history of allergic diseases .
- Clinically significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption.
- Acute illness within 14 days before dosing.
- Severe infection within 6 months before dosing, or chronic/recurrent infections.
- Participant and/or first-degree relative with hereditary immunodeficiency.
- Major trauma or surgery within 3 months before dosing.
Show all 16Show fewer
- History of active/latent TB or contact with an open TB case within 6 months before dosing.
- Positive urine drug screen.
- Alcohol abuse.
- Use of tobacco/nicotine products within 3 months before the first dose.
- Use of any prescription/non-prescription drugs, herbal medicines, supplements within 14 days before first dose; or systemic corticosteroids, immunosuppressants/modulators, hormone replacement therapy within 30 days before first dose; or any other factor affecting drug absorption, distribution, metabolism, and excretion.
- Consumption of caffeine-containing foods/beverages within 48 hours before the first dose.
- Use of known CYP3A4 inducers/inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose.
- Dieting, dietary therapy within 30 days before the first dose.
- Positive for syphilis antibody, HCV-Ab, HBsAg, HBcAb, or HIV-Ab at screening.
- Administration of live vaccines within 6 weeks before the first dose or planned during study or within 8 weeks after study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Gobroad Hospital
Beijing, Beijing Municipality, 102200
Xiaohua Tian
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ICP-538 in Healthy Participants
This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects
- Conditions
- Health Services Research
- Being tested
- ICP-538 Tablets, ICP-538 placebo Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-538 TabletsDrug
ICP-538 will be administered as tablet
ICP-538 placebo TabletsDrug
Matching placebo will be administered as tablet
| Study group | Role | What they receive |
|---|---|---|
| Single ascending doses of ICP-538 tablet | Experimental | Not described Receives: Drug: ICP-538 Tablets |
| Multiple ascending doses of ICP-538 tablet | Experimental | Not described Receives: Drug: ICP-538 Tablets |
| Single ascending doses of placebo | Placebo comparator | Not described Receives: Drug: ICP-538 placebo Tablets |
| Multiple ascending doses of placebo | Placebo comparator | Not described Receives: Drug: ICP-538 placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs).
Measured: Up to 7 weeks
The incidence and severity of abnormal clinical laboratory tests
Incidence and severity of clinically significant laboratory test abnormalities during treatment (including hematology, biochemistry, urinalysis, stool routine, etc.).
Measured: Up to 7 weeks
The incidence of abnormalities in vital signs, physical examination, 12-lead ECG, etc.
The incidence of abnormalities in vital signs, physical examination, 12-lead ECG, etc.
Measured: up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start13 Mar 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Services ResearchStudies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535099
- Sponsor's protocol ID
- ICP-CL-01701
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ICP-538 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07535099
- Acronym / sponsor ID
- ICP-CL-01701
- Conditions
- Health Services Research
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single ascending doses of ICP-538 tablet | Experimental | Drug: ICP-538 Tablets |
| Multiple ascending doses of ICP-538 tablet | Experimental | Drug: ICP-538 Tablets |
| Single ascending doses of placebo | Placebo comparator | Drug: ICP-538 placebo Tablets |
| Multiple ascending doses of placebo | Placebo comparator | Drug: ICP-538 placebo Tablets |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Voluntarily sign the ICF..
- BMI between 18-26 kg/m² (inclusive). Male weight ≥50 kg; female weight ≥45 kg.
- Vital signs, physical examination, ECG, Chest X-ray, Abdominal ultrasound results at screening are within normal range or showing minor deviations deemed not clinically significant by the investigator.
- Laboratory test results at screening and baseline are within the normal reference range.
- Reproductive Status：Females of non-childbearing potential . Male participants and their partners must agree to use effective contraception throughout the study and for 3 months after the last dose. Male participants must not donate sperm during this period.
Key exclusion criteria (16 listed)
- Evidence or history of clinically significant diseases, or Evidence or history of allergic diseases .
- Clinically significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption.
- Acute illness within 14 days before dosing.
- Severe infection within 6 months before dosing, or chronic/recurrent infections.
- Participant and/or first-degree relative with hereditary immunodeficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICP-538 TabletsICP-538 will be administered as tablet | Drug | Multiple ascending doses of ICP-538 tablet, Single ascending doses of ICP-538 tablet |
| ICP-538 placebo TabletsMatching placebo will be administered as tablet | Drug | Multiple ascending doses of placebo, Single ascending doses of placebo |
Primary outcome
Treatment-emergent adverse events (TEAEs)
Time frame: Up to 7 weeks
Incidence and severity of treatment-emergent adverse events (TEAEs).
The incidence and severity of abnormal clinical laboratory tests
Time frame: Up to 7 weeks
Incidence and severity of clinically significant laboratory test abnormalities during treatment (including hematology, biochemistry, urinalysis, stool routine, etc.).
The incidence of abnormalities in vital signs, physical examination, 12-lead ECG, etc.
Time frame: up to 7 weeks
The incidence of abnormalities in vital signs, physical examination, 12-lead ECG, etc.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ICP-538 Tablets in people with Health Services Research, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quankun Zhuang (+86-13011825339, zhuangqk@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (TEAEs) (time frame: Up to 7 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.